1. Articles from Salvatore Brugaletta

    1-24 of 37 1 2 »
    1. Randomized comparison of optical coherence tomography versus angiography to guide Bioresorbable vascular scaffold implantation: The OPTICO BVS stud

      Randomized comparison of optical coherence tomography versus angiography to guide Bioresorbable vascular scaffold implantation: The OPTICO BVS stud

      Purpose We investigated whether optical coherence tomography (OCT)-guided bioresorbable vascular scaffolds (BVS) implantation can improve in-scaffold minimal lumen area (MLA) at 6-month compared with angiography guidance. Methods The OPTICO BVS was a randomized, international multicenter, assessor blind, superiority trial comparing OCT- versus angiography-guided percutaneous coronary intervention (PCI) (1:1 allocation) in patients with coronary artery disease undergoing Absorb BVS 1.1 implantation. The primary endpoint was in-scaffold MLA at 6-month. Results The trial was prematurely stopped on May 31, 2017 after enrollment of 38 of 270 planned patients (14%) following the retraction of the device in Europe. Patients were ...

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    2. Second-generation drug-eluting absorbable metal scaffold target-lesion revascularization: an optical coherence tomography case series study and literature review

      Second-generation drug-eluting absorbable metal scaffold target-lesion revascularization: an optical coherence tomography case series study and literature review

      Bioresorbable scaffolds (BRS) were introduced into clinical practice to overcome long-term limitations of drug-eluting stents (DES), but they were instead associated with a high rate of target lesion revascularization (TLR) and thrombosis. Whereas scaffold discontinuity was the most frequent mechanism for polymeric-BRS TLR1, there are no studies on the causes of second-generation drug-eluting absorbable metal scaffold (MgBRS) TLR (Magmaris, BIOTRONIK, Bulach, Switzerland). We sought to determine the optical coherence tomography (OCT) findings in patients who experienced a MgBRS TLR. Moreover, we performed a systematic review of the reported cases. 

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    3. A serial three- and nine-year optical coherence tomography evaluation of neoatherosclerosis progression after sirolimus- and paclitaxel-eluting stents implantation

      A serial three- and nine-year optical coherence tomography evaluation of neoatherosclerosis progression after sirolimus- and paclitaxel-eluting stents implantation

      Background: Early-generation drug-eluting stents (DES) have been shown to accelerate neoatherogenesis. Limited optical coherence tomography (OCT) data on the very long-term neoatherosclerosis progression after DES implantation are available. Aim: The aim of this study was a serial OCT evaluation of neoatherosclerosis at 3 and 9 years after implantation of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Methods: Consecutive patients undergoing elective PCI with SES (Cypher, Cordis) or PES (Taxus, Boston Scientific) were included in this single-centre, longitudinal study. OCT analysis was performed after 3 and 9 years by the independent core laboratory. Results: A total of 39 OCT recordings were ...

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    4. Quality difference of neointima following the implantation of bioresorbable scaffold and metallic stent in patients with ST elevation myocardial infarction: quantitative assessments by light intensity, light attenuation, and backscatter on optical coheren

      Quality difference of neointima following the implantation of bioresorbable scaffold and metallic stent in patients with ST elevation myocardial infarction: quantitative assessments by light intensity, light attenuation, and backscatter on optical coheren

      Aims: We aimed to assess possible difference of the neointimal quality after everolimus-eluting bioresorbable scaffold (BVS) implantation in comparison with cobalt chromium everolimus-eluting scaffold (CoCr-EES) by optical frequency domain imaging (OFDI). Methods and results: This study is a post-hoc analysis of TROFI II trial assessing neointimal quality 6-month after the implantation of BVS(N=82) and CoCr-EES(N=87) in STEMI patients. Neointimal light property analysis by OFDI full-automatically computed light attenuation, backscatter and light intensity for superficial and deep neointima. High light attenuation/backscatter and high light intensity are reportedly associated with lipidic change and tissue maturation, respectively. Superficial ...

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    5. First serial optical coherence tomography assessment at baseline, 12 and 24 months in STEMI patients treated with the second generation ABSORB™ bioresorbable vascular scaffold

      First serial optical coherence tomography assessment at baseline, 12 and 24 months in STEMI patients treated with the second generation ABSORB™ bioresorbable vascular scaffold

      Aims: The aim of the study was to assess the vascular healing response after Absorb bioresorbable vascular scaffold (BVS) implantation in patients with ST segment elevation myocardial infarction (STEMI) utilizing truly serial optical coherence tomography (OCT) examination at baseline, 12- and 24-months. Methods and results: This is the single-centre, prospective, longitudinal study with baseline, 12- and 24-month OCT evaluation of 18 STEMI patients treated with 22 Absorb BVS implantation. The healing pattern was evaluated based upon lumen area, neointimal hyperplasia, strut coverage and apposition. The lumen area decreased at 12 months compared to baseline (8.52± 1.69 mm2 vs ...

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    6. Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy

      Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy

      Objectives This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES). Background Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes. Methods In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- ...

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    7. Five-Year Optical Coherence Tomography in Patients With ST-Segment–Elevation Myocardial Infarction Treated With Bare-Metal Versus Everolimus-Eluting Stents

      Five-Year Optical Coherence Tomography in Patients With ST-Segment–Elevation Myocardial Infarction Treated With Bare-Metal Versus Everolimus-Eluting Stents

      Background— The main causes of late (>1 month) stent thrombosis (ST) are stent uncoverage, malapposition, and neoatherosclerosis. First-generation drug-eluting stents were associated with higher rate of late ST compared with bare-metal stents (BMS), especially in patients with ST-segment–elevation myocardial infarction. Second-generation everolimus-eluting stents (EES) have shown similar rate of late ST than BMS. The aims of the study are to compare the ratio of uncovered to total struts per cross-section ≥30% and other optical coherence tomographic findings associated with ST between EES and BMS in patients with ST-segment–elevation myocardial infarction at 5 years. Methods and Results— One hundred ...

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    8. Letter by Garcia-Garcia and Brugaletta Regarding Article, “Optical Coherence Tomography–Guided Percutaneous Coronary Intervention in ST-Segment–Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneou

      Letter by Garcia-Garcia and Brugaletta Regarding Article, “Optical Coherence Tomography–Guided Percutaneous Coronary Intervention in ST-Segment–Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneou

      Sheth et al 1 compared optical coherence tomography (OCT)–guided versus angiography-guided primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction among patients in the TOTAL trial (Thrombectomy Versus Percutaneous Coronary Intervention Alone). Patients (n=214) were imaged with OCT and were propensity-matched with 428 patients who had angio-guided percutaneous coronary intervention. There were clear OCT guidelines for stent optimization; however, operator compliance to follow those guidelines and whether optimal results were achieved are not reported. This makes us wonder whether the investigator’s good intentions were actually executed and were effective. Hence, it is uncertain whether the OCT group ...

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    9. Serial optical coherence tomography assessment of malapposed struts after everolimus-eluting stent implantation. A subanalysis from the HEAL-EES study

      Serial optical coherence tomography assessment of malapposed struts after everolimus-eluting stent implantation. A subanalysis from the HEAL-EES study

      Background Incomplete stent apposition (ISA) is related to stent thrombosis, which is a serious adverse event. We aim to assess the time-course of ISA after 2nd generation everolimus-eluting stent (EES) implantation. Methods In HEAL-EES study, we enrolled 36 patients who underwent percutaneous coronary intervention (PCI) with EES. OCT imaging was performed at baseline and follow-up. Patients were randomized 1:1:1 into 3 groups according to the time in which follow-up was performed: group A (6-month), group B (9-month), and group C (12-month). In this subanalysis, patients who had ISA segments at baseline and/or follow-up OCT were analyzed. Result ...

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    10. Letter by Garcia-Garcia and Brugaletta Regarding Article, "Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneou

      Letter by Garcia-Garcia and Brugaletta Regarding Article, "Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneou

      Sheth et al 1 compared optical coherence tomography (OCT)–guided versus angiography-guided primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction among patients in the TOTAL trial (Thrombectomy Versus Percutaneous Coronary Intervention Alone). Patients (n=214) were imaged with OCT and were propensity-matched with 428 patients who had angio-guided percutaneous coronary intervention. There were clear OCT guidelines for stent optimization; however, operator compliance to follow those guidelines and whether optimal results were achieved are not reported. This makes us wonder whether the investigator’s good intentions were actually executed and were effective. Hence, it is uncertain whether the OCT group ...

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    11. Optical coherence tomography: A pathway from research to clinical practice

      Optical coherence tomography: A pathway from research to clinical practice

      For more than half a century, coronary angiography has been the goldstandard diagnostic test for the assessment of coronary artery disease, but it does not provide information about the components of the vascular wall, atherosclerosic disease burden, or the interaction of local devices with coronary artery walls.  The development of intracoronary imaging techniques, such as optical coherence tomography (OCT), was conceived with the objective to overcome coronary angiography limitations.

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    12. Overtime evaluation of the vascular HEALing process after Everolimus-Eluting Stent implantation by optical coherence tomography. The HEAL-EES study

      Overtime evaluation of the vascular HEALing process after Everolimus-Eluting Stent implantation by optical coherence tomography. The HEAL-EES study

      Purpose Second-generation drug-eluting stent (DES) have shown a better safety and efficacy as compared to first generation DES due to an improved vascular healing process. This process has not been so far evaluated in vivo in an overtime fashion by optical coherent tomography (OCT). We sought to evaluate the vascular healing process after everolimus-eluting stent (EES) implantation at 6, 9 and 12 months, by OCT. Methods Consecutive 36 patients undergoing percutaneous coronary intervention with EES were randomized 1:1:1 to receive OCT imaging at 6 (group A), 9 (group B) or 12-month follow-up (group C). One patient from group ...

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    13. A 12–month angiographic and optical coherence tomography follow-up after bioresorbable vascular scaffold implantation in patients with ST-segment elevation myocardial infarction

      A 12–month angiographic and optical coherence tomography follow-up after bioresorbable vascular scaffold implantation in patients with ST-segment elevation myocardial infarction

      Objectives The aim of the study was to evaluate the healing process at 12 months after ABSORB™ bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). Background There is currently no data on long-term BVS performance in the acute thrombotic setting. The underlying altered plaque pathomorphology may impact the neointima healing pattern, potentially making it different to that observed in stable coronary artery disease (CAD). Methods We have performed an angiographic and optical coherence tomography (OCT) 12-month follow-up of 19 STEMI patients who were treated with a BVS implantation (23 scaffolds). An independent core laboratory performed ...

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    14. A 12-month angiographic and optical coherence tomography follow-up after bioresorbable vascular scaffold implantation in patients with ST-segment elevation myocardial infarction

      A 12-month angiographic and optical coherence tomography follow-up after bioresorbable vascular scaffold implantation in patients with ST-segment elevation myocardial infarction

       Objectives The aim of the study was to evaluate the healing process at 12 months after ABSORB™ bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). Background There is currently no data on long-term BVS performance in the acute thrombotic setting. The underlying altered plaque pathomorphology may impact the neointima healing pattern, potentially making it different to that observed in stable coronary artery disease (CAD). Methods We have performed an angiographic and optical coherence tomography (OCT) 12-month follow-up of 19 STEMI patients who were treated with a BVS implantation (23 scaffolds). An independent core laboratory performed ...

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    15. Optical coherence tomography appraisal of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing intraprocedural versus post-stenting prolonged bivalirudin infusion. Rationale and design of the MATRIX (Minimizing A

      Optical coherence tomography appraisal of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing intraprocedural versus post-stenting prolonged bivalirudin infusion. Rationale and design of the MATRIX (Minimizing A

      Aims: Residual thrombus accumulation around stent struts has been observed after the end of primary PCI and may represent a risk factor for acute stent thrombosis. The aim of this study is to test whether a strategy of prolonged bivalirudin infusion may reduce thrombosis of stent struts as compared to an intraprocedural only administration in subjects undergoing primary PCI. Methods and results: One hundred and sixty patients will be selected from the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) study with all the following inclusion criteria: a) STEMI patients undergoing primary PCI with stent implantation, b ...

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    16. Frequency and predictors of thrombus inside the guiding catheter during interventional procedures: an optical coherence tomography study

      Frequency and predictors of thrombus inside the guiding catheter during interventional procedures: an optical coherence tomography study

      Optical coherence tomography (OCT) is able to identify thrombus. We detect the frequency of thrombus inside the guiding catheter by OCT and its relationship with clinical and procedural factors. We screened 77 patients who underwent OCT pullbacks. Only patients with visible guiding catheter were finally included (35) and divided into thrombus (21) or no-thrombus group (14). Patients within thrombus group were mostly males (100 vs. 71 %, p = 0.05), with acute coronary syndrome (76 vs. 36 %, p = 0.02) and received more frequently percutaneous coronary intervention (86 vs. 43 %, p = 0.01) as compared to other group. A second dose ...

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    17. Coronary evaginations are associated with positive vessel remodelling and are nearly absent following implantation of newer-generation drug-eluting stents: an optical coherence tomography and intravascular ultrasound study

      Coronary evaginations are associated with positive vessel remodelling and are nearly absent following implantation of newer-generation drug-eluting stents: an optical coherence tomography and intravascular ultrasound study

      Objectives The purpose of this study was to assess the occurrence, predictors, and mechanisms of optical coherence tomography (OCT)-detected coronary evaginations following drug-eluting stent (DES) implantation. Background Angiographic ectasias and aneurysms in stented segments have been associated with a risk of late stent thrombosis. Using OCT, some stented segments show coronary evaginations reminiscent of ectasias. Methods Evaginations were defined as outward bulges in the luminal contour between struts. They were considered major evaginations (MEs) when extending ≥3 mm along the vessel length, with a depth ≥10% of the stent diameter. A total of 228 patients who had sirolimus (SES ...

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    18. One-year head to head comparison of the neointimal response between sirolimus eluting stent with reservoir technology and everolimus eluting stent. An optical coherence tomography study

      One-year head to head comparison of the neointimal response between sirolimus eluting stent with reservoir technology and everolimus eluting stent. An optical coherence tomography study

      Objective: to compare the vascular healing process between the sirolimus-eluting NEVO and the everolimus-eluting Xience stent by optical coherence tomography (OCT) at 1-year follow-up. Background: Presence of durable polymer on a drug-eluting metallic stent may be the basis of an inflammatory reaction with abnormal healing response. The NEVO stent, having a bioresorbable polymer eluted by reservoir technology, may overcome this problem. Methods: All consecutive patients, who received NEVO or Xience stent implantation between September 2010 and October 2010 in our institution, were included. Vascular healing was assessed at 1-year as percentage of uncovered struts, neointimal thickness, in-stent / stent area obstruction ...

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    19. Differences in Neointimal Thickness Between the Adluminal and the Abluminal Sides of Malapposed and Side-Branch Struts in a Polylactide Bioresorbable Scaffold: Evidence In Vivo About the Abluminal Healing Process

      Differences in Neointimal Thickness Between the Adluminal and the Abluminal Sides of Malapposed and Side-Branch Struts in a Polylactide Bioresorbable Scaffold: Evidence In Vivo About the Abluminal Healing Process

      Objectives: The goal of this study was to describe the neointimal healing on the abluminal side (ABL) of malapposed (ISA) struts and nonapposed side-branch (NASB) struts in terms of coverage by optical coherence tomography (OCT) and in comparison with the adluminal side (ADL).Background: The neointimal healing on the ABL of ISA and NASB struts has never to our knowledge been explored in vivo and could be involved in the correction of acute malapposition. The bioresorbable vascular scaffold (BVS) is made of a translucent polymer that enables imaging of the ABL with OCT. Methods: Patients enrolled in the ABSORB B ...

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    20. Reproducibility of qualitative assessment of stent struts coverage by optical coherence tomography

      Reproducibility of qualitative assessment of stent struts coverage by optical coherence tomography

      Abstract  Assessment of stent strut coverage by optical coherence tomography (OCT) is not standardized. The methodology most commonly used is based on a visual binary qualitative assessment (strut covered or not). However, the influence of magnification (zoom setting) to the inter- and intra-observer agreements has not yet been evaluated. Aim of our study was therefore to evaluate the agreements of this approach, taking into account various zoom settings. 126 struts from 10 selected frames were independently evaluated by four observers using a stepwise approach increasing the zoom setting as following: (1) full view of the lumen (FV), (2) half view ...

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    21. Circumferential evaluation of the neointima by optical coherence tomography after ABSORB bioresorbable vascular scaffold implantation: Can the scaffold cap the plaque?

      Circumferential evaluation of the neointima by optical coherence tomography after ABSORB bioresorbable vascular scaffold implantation: Can the scaffold cap the plaque?

      Objective To quantify the circumferential healing process at 6 and 12 months following scaffold implantation. Background The healing process following stent implantation consists of tissue growing on the top of and in the space between each strut. With the ABSORB bioresorbable vascular scaffold (BVS), the outer circumference of the scaffold is detectable by optical coherence tomography (OCT), allowing a more accurate and complete evaluation of the intra-scaffold neointima. Methods A total of 58 patients (59 lesions), who received an ABSORB BVS 1.1 implantation and a subsequent OCT investigation at 6 (n = 28 patients/lesions) or 12 (n = 30 patients ...

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    22. Head to head comparison of optical coherence tomography, intravascular ultrasound echogenicity and virtual histology for the detection of changes in polymeric struts over time: insights from the ABSORB trial

      Head to head comparison of optical coherence tomography, intravascular ultrasound echogenicity and virtual histology for the detection of changes in polymeric struts over time: insights from the ABSORB trial

      Aims: To analyse and to compare the changes in the various optical coherence tomography (OCT), echo-genicity intravascular ultrasound virtual histology (VH) of the everolimus-eluting bioresorbable scaffold (ABSORB) degradation parameters during the first 12 months after ASOERB implantation.

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    23. Head-to-Head Comparison of the Neointimal Response Between Metallic and Bioresorbable Everolimus-Eluting Scaffolds Using Optical Coherence Tomography

      Head-to-Head Comparison of the Neointimal Response Between Metallic and Bioresorbable Everolimus-Eluting Scaffolds Using Optical Coherence Tomography

      The metallic everolimus drug-eluting stents (DES) and polymeric everolimus bioresorbable vascular scaffolds (BVS) are coated with the same antiproliferative drug. It is uncertain if, during the bioresorption process, the neointimal response of everolimus BVS differs from that of everolimus DES. A total of 31 lesions treated with a single everolimus BVS, and 19 lesions treated with everolimus DES and imaged with optical coherence tomography at 1 year, were investigated. Neointimal response was assessed as a percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima. Both scaffolds presented with similar neointimal response. However, the everolimus BVS ...

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    24. Three-dimensional optical frequency domain imaging in conventional percutaneous coronary intervention: the potential for clinical application

      Three-dimensional optical frequency domain imaging in conventional percutaneous coronary intervention: the potential for clinical application

      Two-dimensional (2D) frequency domain optical coherence tomography (FD-OCT) has enhanced our understanding of coronary atherosclerotic disease and is increasingly being used in conventional percutaneous coronary intervention (PCI) to elucidate mechanisms of disease and improve our understanding of complex coronary anatomy. Since the first report of three-dimensional (3D) OCT applied in human coronary vessels,1 the technology has rapidly progressed.2–10 Currently, the main limitation of this technology is the need for off-line creation of 3D reconstructions—prototypes of current generation ‘real time’ (i.e. available peri-procedurally at the ‘push-of-a-button’) remain experimental, work in progress, and are limited by relatively ...

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    1-24 of 37 1 2 »
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    1. (36 articles) Salvatore Brugaletta
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    A comparative assessment by optical coherence tomography of the performance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds Optical coherence tomography (OCT) of overlapping bioresorbable scaffolds: from bench-work to clinical application Quantitative multi-modality imaging analysis of a fully bioresorbable stent: a head-to-head comparison between QCA, IVUS, and OCT NIRS and IVUS for Characterization of Atherosclerosis in Patients Undergoing Coronary Angiography Healing of a coronary artery dissection detected by intravascular ultrasound and optical coherence tomography. Assessment of Coronary Atherosclerosis Progression and Regression at Bifurcations Using Combined IVUS and OCT Optical coherence tomography (OCT) of overlapping bioresorbable scaffolds: from benchwork to clinical application Serial Analysis of the Malapposed and Uncovered Struts of the New Generation of Everolimus-Eluting Bioresorbable Scaffold With Optical Coherence Tomography Angiographic maximal luminal diameter and appropriate deployment of the everolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography: an ABSORB cohort B trial sub-study Circumferential evaluation of the neointima by optical coherence tomography after ABSORB bioresorbable vascular scaffold implantation: Can the scaffold cap the plaque? Optical coherence tomography angiography (OCTA) findings in Serpiginous Choroiditis Changes in retinal layer thickness with maturation in the dog: an in vivo spectral domain - optical coherence tomography imaging study